Events

Recall of Total Knee

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Ossur H / F.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53127
  • Event Risk Class
    Class 2
  • Event Number
    Z-0965-2012
  • Event Initiated Date
    2009-08-10
  • Event Date Posted
    2012-02-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84735
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Joint, knee, external limb component - Product Code ISY
  • Reason
    Some units of the total knee junior produced between november 25th, 2008 and through april, 2009 contain balancing units that may fail under extreme use over a long period. the fault is noncritical and no incidents or injuries resulting from this situation have been reported to ossur at this stage. over long term use (estimated to be in the four to six year range) the prosthetic device may fail a.
  • Action
    Ossur sent a Safety Notice dated August 10, 2009 by mailed to all affected consignees. Ossur informed consignees of the above mentioned public reason for recall and asked consignees to take the following action: Identify the users of each of the Total Knee Junior model devices listed above and check inventory and isolate any recalled devices on hand but have not fitted on users. The letter states that Sue Fitzgerald from customer service will be contacting consignees in the next few days to coordinate replacement of the affected devices. For question call 1-(800) 219-2150, Ext: 4109. In addition, Ossur website: www.ossur.com we will be posting updates as appropriate.

Device

Total Knee
  • Model / Serial
    Serial Numbers: 8573, 8574, 8575, 8577, 8578, 8580, 8581, 8582, 8583, 8584, 8585, 8586, 8587, 8588, 8589, 8599, 8600, 8602, 8603, 8604, 8605, 8606, 8609, 8610, 8611, 8613, 8616, 8620, 8621, 8622, 8624, 8628, 8629, 8630, 8631, 8632, 8633, 8634, 8635, 8636, 8638, 8639, 8640, 8642, 8643, 8644, 8645, 8646, 8666, 8670, 8671, 8672, 8673, 8674, 8675, 8678, 8679, 8680, 8682, 8684, 8685, 8687, 8688, 8691, 8692, 8693, 8694, 8695, 8696, 8697, 8698, 8699, 8701, 8715, 8716, 8717, 8719, 8720, 8722, 8723, 8725, 8739, 8755, 8756, 8757, 8758, 8759, 8760, 8761, 8784, 8787.
  • Product Classification
    Physical Medicine Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) in the state of: AL, AR, AZ, CA, CO, DE, FL, GA, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NV, NY, OH, OK, OR, PA, SC, TX, and WV and the countries of: Australia, Canada, China, France, Germany, Hong Kong, Israel, Japan, Malaysia, Netherlands, New Zealand, Portugal, Puerto Rico, Saudi Arabia, South Africa, Spain, Sweden, Taiwan, United Kingdom and United States.
  • Product Description
    Total Knee Junior Model Number 1100 || Product Usage: || The Total Knee¿ Junior is an external polycentric prosthetic knee with a geometric locking system.
  • Manufacturer
    Ossur H / F

Manufacturer

Ossur H / F
  • Manufacturer Address
    Ossur H / F, Grjothals 5, Reykjavik Iceland
  • Manufacturer Parent Company (2017)
    Össur hf
  • Source
    USFDA